POLYMER TECHNOLOGY SYSTEMS, INC.

Address:510 Oakmead Pkwy,SUNNYVALE,CA,94085,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL (CHH) (5) LDL & VLDL PRECIPITATION, HDL (LBR) (5) COLORIMETRIC METHOD, TRIGLYCERIDES (JGY) (4) GLUCOSE OXIDASE, GLUCOSE (CGA) (4) LIPOPROTEIN, HIGH DENSITY, HDL, OVER THE COUNTER (NAQ) (3) SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER (NBW) (3) TEST, TRIGLYCERIDES, OVER THE COUNTER (NGO) (2) Multi-analyte controls, all kinds (assayed) (JJY) (2) Single (specified) analyte controls (assayed and unassayed) (JJX) (1)

Premarket Exempt

No Yes

Clear

pts panels® Multi-Chemistry Controls - 00381930721013 Catalog Number : 721

Device Description : PTS PANELS® Multi-Chemistry Controls contain cholesterol, triglycerides, glucose

Device Class : 1

Duns Number: 835772872

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

pts panels® HDL Cholesterol Controls - 00381930722010 Catalog Number : 722

Device Description : PTS PANELS® HDL Cholesterol Controls contain cholesterol. The analyte(s) in each

Device Class : 1

Duns Number: 835772872

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

A1CNow+ Controls™ Levels 1+2 - 00381930737014 Catalog Number : 737

Device Description : The A1CNow+ Controls™ are supplied in two levels as a frozen, ready-to-use mater

Device Class : 1

Duns Number: 835772872

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

ChekMate™ Strips - 00381930860019 Catalog Number : 860

Device Description : ChekMate™ Strips are dry strips that mimic the use of the PTS Panels test strips

Device Class :

Duns Number: 835772872

Premarket Exempt : No

Product Code : CHH, CGA, LBR, JGY

Prescription Use : Yes

Device Count : 2

CardioChek® PA analyzer - 00381931708013 Catalog Number : 1708

Device Description : The CardioChek® PA professional analyzer is intended for in vitro diagnostic use

Device Class : 1

Duns Number: 835772872

Premarket Exempt : No

Product Code : NAQ, CGA, LBR, CHH, JGY, NGO, NBW

Prescription Use : Yes

Device Count : 1

CardioChek® analyzer - 00381931709010 Catalog Number : 1709

Device Description : The CardioChek® analyzer is intended for in vitro diagnostic use to test whole b

Device Class : 1

Duns Number: 835772872

Premarket Exempt : No

Product Code : LBR, NBW, NGO, JGY, NAQ, CHH, CGA

Prescription Use : Yes

Device Count : 1

PTS Panels® Lipid Panel Test Strips - 00381931710016 Catalog Number : 1710

Device Description : PTS Panels® Lipid Panel test strips are in vitro diagnostic devices used to moni

Device Class :

Duns Number: 835772872

Premarket Exempt : No

Product Code : JGY, CHH, LBR

Prescription Use : Yes

Device Count : 15

PTS Panels® Cholesterol Test Strips - 00381931711013 Catalog Number : 1711

Device Description : PTS Panels® Cholesterol test strips are in vitro diagnostic devices used to moni

Device Class :

Duns Number: 835772872

Premarket Exempt : No

Product Code : CHH

Prescription Use : Yes

Device Count : 25

PTS Panels® Glucose Test Strips (25-ct) - 00381931713017 Catalog Number : 1713

Device Description : PTS Panels® glucose test strips are in vitro diagnostic devices used to monitor

Device Class :

Duns Number: 835772872

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : Yes

Device Count : 25

PTS Panels® HDL Cholesterol Test Strips - 00381931714014 Catalog Number : 1714

Device Description : PTS Panels® HDL Cholesterol test strips are in vitro diagnostic devices used to

Device Class :

Duns Number: 835772872

Premarket Exempt : No

Product Code : LBR, NAQ

Prescription Use : Yes

Device Count : 25

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